Job Details

  • Title: Batch Release Manager
  • Code: RCI-02767
  • Location: Swiftwater Pennsylvania (PA) 18370
  • Posted Date: 08/10/2020
  • Duration: 12 Months
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  Job Description

The Product Quality Batch Release (PQBR) Manager will perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met.

 Responsibilities:
o Quality Review of Batch Records
o Preparation & Certification of Working Documents
o Quality Review of Lot Release Protocol (LRP)
o Compliance and Performance

Required:
o Working knowledge of cGMPs and regulatory requirements
o Knowledge of vaccines/biologics products and associated technologies
o The ability to work on cross functional project teams
o Meet/Exceed project timelines/deliverables
o Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
o years in a cGMP/ controlled, Quality environment in the pharmaceutical industry